The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able ...

The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple ...

The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...

A real-world study of pegcetacoplan for treatment of geographic atrophy showed significantly better outcomes than the pivotal clinical trials in patients who had symptomatic vision loss.

Analyst Derek Archila of Wells Fargo assigned a Hold rating on Apellis Pharmaceuticals (APLS – Research Report), retaining the price ...

European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for ...

Joseph Stringer has given his Buy rating due to a combination of factors, one of which is the anticipated market share that Apellis Pharmaceuticals’ drug Syfovre is expected to hold. Even though ...

Ginkgo Bioworks is pivoting: Once a synthetic biology darling, the flailing company has now turned to AI-driven protein ...

Syfovre subsequently won an FDA nod in GA in February of 2023. As for the CHMP’s rationale behind its rejection, the agency said that while Syfovre’s phase 3 OAKS and DERBY studies showed that ...

The analyst noted that while the EU's decision was disappointing, especially considering Syfovre's strong performance and demand in the U.S. market, it was not entirely unexpected. According to the ...